Study Evaluating Denosumab on Bone and Vascular Metabolism in Osteoporotic Chronic Kidney Disease

Randomized Controlled Study Evaluating the Effect of a Biotherapy Treatment (Anti-RANKL Ligand Antibody: Denosumab) on Bone and Vascular Metabolism in Osteoporotic Chronic Kidney Disease

Aim of this study is to evaluate in a population of old osteoporotic chronic kidney disease females the effect of denosumab:

• on bone mineral density (femoral T-score) at 24 months
• on bone mineral density evolution (femoral T-score) after 24 months of follow-up
• on bone mineral density evolution (lumbar T-score) after 24 months of follow-up
• on coronary and abdominal aorta calcification scores evolution after 24 months of follow-up
• on parameters of bone remodelling (OPG, RANKL, sclerostin, DKK-1), of mineral and calcium metabolism (FGF23 Ct, Klotho, PTH, 25(OH) vitamin D3, phosphorus, calcium, bone alklaline phosphatase, osteocalcin, CTX), of inflammation (CRP) after 24 months of follow-up
• on cardiovascular morbidity (cardiovascular events) and mortality after 24 months of follow-up
• the tolerance after 24 months of follow-up

Aim of this study is to evaluate in a population of old osteoporotic chronic kidney disease females the effect of denosumab:

• on bone mineral density (femoral T-score) (by bone densitometry) at 24 months
• on bone mineral density evolution (femoral T-score) (by bone densitometry) after 24 months of follow-up
• on bone mineral density evolution (lumbar T-score) (by bone densitometry) after 24 months of follow-up
• on coronary and abdominal aorta calcification scores evolution (by multiple detector computed tomography and plain abdominal X-ray) after 24 months of follow-up
• on parameters of bone remodelling (OPG, RANKL, sclerostin, DKK-1), of mineral and calcium metabolism (FGF23 Ct, Klotho, PTH, 25(OH) vitamin D3, phosphorus, calcium, bone alklaline phosphatase, osteocalcin, CTX), of inflammation (CRP) after 24 months of follow-up
• on cardiovascular morbidity (cardiovascular events) and mortality after 24 months of follow-up
• the tolerance after 24 months of follow-up

Inclusion Criteria:

• Patient of 65 years or older
• Chronic kidney disease stage 5 patient, hemodialyzed with extracorporeal treatment for at least 3 months
• Patient with osteoporosis (history of bone fracture or T-scoring < -2.5 SD)
• PTH levels in the serum in agreement with the KDIGO guidelines, in the absence of treatment with Cinacalcet.

Exclusion Criteria:

• Cinacalcet treatment
• Calcium parameters (PTH, 25(OH) vitamin D3, Calcium) outside the KDIGO guidelines
• Suspicion of lower bone remodeling
• Hypersensibility to active substance or one of excipients of denosumab
• Patient with a cancer or myeloma
• Patient with severe heaptic cytolysis
• Patients with severe teeth problems
• Patient positive for HIV
• Patient involved in another biomedical research
• Vulnerable patients (protected by the law, under guardianship, deprived of freedom)